European Drug Utilization Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

814 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-24

Study Completion Date

2014-03-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this retrospective observational study is to evaluate the characteristics of patients receiving Seroquel XR as treatment for their Major Depressive Disorder. The study will also investigate how the medication is used for these patients and if there are any differences in drug utilisation between the included countries. The study is observing patients initiating Seroquel XR during a 9 month period corresponding to 3 to 12 months following the launch of the product in each country for the MDD indication. A drug utilisation questionnaire will be used to collect study data from patients' medical records.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

A Multinational, Multicenter, Retrospective, Observational Drug Utilisation Study of Seroquel Extended Release (XR) Prescribed by Psychiatrists as Treatment for Major Depressive Disorder (MDD) in Selected Countries in the European Union (EU)

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Major Depressive Disorder (MDD)

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Seroquel XR Quetiapine XR Drug utilization Major depressive disorder (MDD)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Seroquel XR group

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Provision of informed consent before initiation of any collection of questionnaire data.
* Documented clinical diagnosis of Major Depressive Disorder, Single Episode, or Recurrent.
* Initiation of Seroquel XR for treatment of MDD during the period defining the inception cohort, i.e. from 3 months after launch until the index date (12 months after launch).

Exclusion Criteria

* If participating in any clinical trial during the time from 3 months after launch until the index date, the patient cannot take part in this study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hans A Eriksson, MD

Role: STUDY_DIRECTOR

AstraZeneca R&D

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

Dortmund, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

D1443C00057

Identifier Type: -

Identifier Source: org_study_id